Trial · NCT02292446

Expanded Treatment Protocol (ETP) of Ruxolitinib in Patients With Polycythemia Vera Who Were Hydroxyurea Resistant or Intolerant and for Whom no Treatment Alternatives Was Available.

NCT02292446, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2019-04-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Expanded Treatment Protocol (ETP) of Ruxolitinib in Patients With Polycythemia Vera Who Were Hydroxyurea Resistant or Intolerant and for Whom no Treatment Alternatives Was Available. Trials, record NCT02292446. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02292446

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Expanded Treatment Protocol (ETP) of Ruxolitinib in Patients With Polycythemia Vera Who Were Hydroxyurea Resistant or Intolerant and for Whom no Treatment Alternatives Was Available.
NCT number: NCT02292446
Status: Completed
Phases: Phase 3
Enrollment: 161 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Polycythemia Vera
Interventions: Ruxolitinib
First posted: 2014-11-17
Last updated: 2019-07-18
Results first posted: 2019-04-02

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Adverse Events - All Grades	Baseline up to approximately 26 months	Summary of adverse events (all grades).
Secondary	Change From Baseline in Hematocrit Levels at All Visits	Up to approximately 26 months	Change in hematocrit levels from Baseline to each visit were measured
Secondary	Change From Baseline in Spleen Length	Up to approximately 26 months	Change in spleen length from Baseline to each visit
Secondary	Change From Baseline in Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS)	Up to approximately 26 months	The MPN-SAF (Appendix 6) was a disease specific questionnaire comprised of 10 items that measures fatigue related to MPN disease and the severity of nine of the most prevalent associated symptoms including: early satiety, abdominal discomfort, inactivity, concentration, night sweats, itching, bone pain, fever and weight loss. There were three recall periods used in this questionnaire, which were 24 hours for fatigue, the past week for symptoms of early satiety, abdominal discomfort, inactivity, concentration, night sweats, itching, bone pain and fever, and the past 6 months for weight loss, Each item was scored on a scale ranging from 0 (no fatigue/absent) to 10 (As bad as you can imagine/worst imaginable). The MPN-SAF TSS was computed as the average of the observed items multiplied by 10 to achieve a 0-to-100 scale. The MPN-SAF TSS thus had a possible score range of 0 to 100.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Adverse Events - All Grades	Baseline up to approximately 26 months		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline in Hematocrit Levels at All Visits	Up to approximately 26 months	Number of participants qualifying for evaluation of change from baseline varied across visits	percentage	MEAN
SECONDARY	Change From Baseline in Spleen Length	Up to approximately 26 months	Number of participants qualifying for evaluation of change from baseline varied across visits	cm	MEAN
SECONDARY	Change From Baseline in Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS)	Up to approximately 26 months	Number of participants qualifying for evaluation of change from baseline varied across visits	scores	MEAN

Source ClinicalTrials.gov

Results by group95

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Participants With Adverse Events - All Grades	All Patients	Adverse events	143		Participants
Number of Participants With Adverse Events - All Grades	All Patients	Serious adverse events	26		Participants
Change From Baseline in Hematocrit Levels at All Visits	Baseline	Week 4	45.26	Standard Deviation 5.246	percentage
Change From Baseline in Hematocrit Levels at All Visits	Post-baseline	Week 4	43.70	Standard Deviation 5.220	percentage
Change From Baseline in Hematocrit Levels at All Visits	Change	Week 4	-1.55	Standard Deviation 3.652	percentage
Change From Baseline in Hematocrit Levels at All Visits	Baseline	Week 8	45.21	Standard Deviation 5.136	percentage
Change From Baseline in Hematocrit Levels at All Visits	Post-baseline	Week 8	40.73	Standard Deviation 4.967	percentage
Change From Baseline in Hematocrit Levels at All Visits	Change	Week 8	-4.48	Standard Deviation 5.055	percentage
Change From Baseline in Hematocrit Levels at All Visits	Baseline	Week 12	45.44	Standard Deviation 5.324	percentage
Change From Baseline in Hematocrit Levels at All Visits	Post-baseline	Week 12	39.97	Standard Deviation 5.419	percentage

1 to 10 of 95Source ClinicalTrials.gov

See all 95 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	All Patients	161
Overall Study	COMPLETED	All Patients	141
Overall Study	NOT COMPLETED	All Patients	20

Source ClinicalTrials.gov

Adverse events45

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	All Patients	35	161
other	Thrombocytosis	Blood and lymphatic system disorders	All Patients	11	161
other	Constipation	Gastrointestinal disorders	All Patients	14	161
other	Diarrhoea	Gastrointestinal disorders	All Patients	15	161
other	Asthenia	General disorders	All Patients	12	161
other	Fatigue	General disorders	All Patients	14	161
other	Nasopharyngitis	Infections and infestations	All Patients	9	161
other	Weight increased	Investigations	All Patients	13	161
other	Dizziness	Nervous system disorders	All Patients	12	161
other	Headache	Nervous system disorders	All Patients	27	161

1 to 10 of 45Source ClinicalTrials.gov

See all 45 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	All Patients	1	161
Total, other adverse events	All Patients	107	161
Total, serious adverse events	All Patients	26	161

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02292446

GET https://conductscience.org/api/trials/v1/NCT02292446/results?page=2

API reference For AI assistants